Ignite Creation Date:
2024-05-05 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 9:18 AM
Study NCT ID:
NCT00204438
Status:
COMPLETED
Last Update Posted:
2016-11-28
First Post:
2005-09-12
Brief Title:
Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle
Sponsor:
University of Saskatchewan
Organization:
University of Saskatchewan
Study Overview
Official Title:
Follicular Profiles After Administration of Oral Contraceptives at Different Times of the Follicular Phase of the Menstrual Cycle
Status:
COMPLETED
Status Verified Date:
2016-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We hypothesize that administration of OCs at varying follicular diameters will provide an appropriate model for the study of follicular atresia in women Clinically we hypothesize that the administration on OCs at different stages of the follicular phase will result in markedly different patterns of follicular development andor atresia
Detailed Description:
This study is a single-centre randomized open-label double-controlled protocol to study the patterns of ovarian follicular growth and regression in women administered 015mg desogestrel 003mg ethinyl estradiol at different stages of the follicular phase of the menstrual cycle
We tracked the growth and regression of dominant follicles after administration of OC by means of highly sophisticated transvaginal ultrasonography and computerized image analysis techniques The extremely high resolution ultrasonography of the ovarian follicles and the computer-assisted image analysis are unique to the Womens Health Imaging Research Laboratory WHIRL at the University of Saskatchewan The synergyne RA Pierson image analysis program was developed in the WHIRL and has the ability to allow assessment of the physiologic status of follicles as small as 6 to 10 mm This unique protocol will allow us to characterize patterns of follicular growth and atresia under the suppressive effects of oral contraception as well as the assessment of anovulatory follicles which may develop when OCs are administered at advanced stages of follicular development
The working hypothesis is that the administration of monophasic OCs prior to and during the time of physiologic selection of the dominant follicle will prevent the development of an ovulatory follicle selection occurs when the dominant follicle reaches 10mm Baerwald Pierson unpublished data In addition we hypothesize that administration of OCs after selection of the dominant follicle at more advanced stages of follicular development will result in 1 of 4 scenarios 1 Ovulation of the dominant follicle 2 Regression of the dominant follicle 3 Formation of a Hemorrhagic Anovulatory follicle HAF or Luteinized Unruptured Follicle LUF or 4 Formation of a follicular cyst We hypothesize that atresia of dominant follicles and formation of anovulatory follicular structures will be associated with limited endometrial development In testing these hypotheses we will determine if OCs can safely and effectively be administered at any time during the follicular phase of the menstrual cycle
This study will evaluate the ovarian and uterine responses to administration of a combined dose of 015mg desogestrel 003mg ethinyl estradiol at 1 of 3 different stages of the follicular phase of the menstrual cycle The objectives of the trial are to
Develop new and more user-friendly administration schemes for OC use
Use the administration of OCs at different stages of follicular development in women as a model for studying follicular atresia
Assess the differences in kinetics physiologic status state of viability or atresia and ultrasonographic image attributes of follicles which grow regress ovulate or form anovulatory follicular structures after the administration of exogenous steroid hormones
Assess endometrial response to ovarian suppression by ultrasonographic evaluation of endometrial thickness and endometrial pattern
After screening measurements confirm subject eligibility subjects will be randomized to initiate OC therapy at one of three different times of the menstrual cycle
Experimental Group 1 receives OCs when the dominant follicle reaches 10mm Experimental Group 2 receives OCs when the dominant follicle reaches 14mm Experimental Group 3 receives OCs when the dominant follicle reaches 18mm
Fifteen women will be randomized to each of the 3 experimental groups in a stratified design scheme Data collected from an ongoing OC trial BMC 2000-169 will serve as OC control data n15 Data collected from a previous study BMC 1988-80 will serve as natural cycle control data n60
We tracked the growth and regression of dominant follicles after administration of OC by means of highly sophisticated transvaginal ultrasonography and computerized image analysis techniques The extremely high resolution ultrasonography of the ovarian follicles and the computer-assisted image analysis are unique to the Womens Health Imaging Research Laboratory WHIRL at the University of Saskatchewan The synergyne RA Pierson image analysis program was developed in the WHIRL and has the ability to allow assessment of the physiologic status of follicles as small as 6 to 10 mm This unique protocol will allow us to characterize patterns of follicular growth and atresia under the suppressive effects of oral contraception as well as the assessment of anovulatory follicles which may develop when OCs are administered at advanced stages of follicular development
The working hypothesis is that the administration of monophasic OCs prior to and during the time of physiologic selection of the dominant follicle will prevent the development of an ovulatory follicle selection occurs when the dominant follicle reaches 10mm Baerwald Pierson unpublished data In addition we hypothesize that administration of OCs after selection of the dominant follicle at more advanced stages of follicular development will result in 1 of 4 scenarios 1 Ovulation of the dominant follicle 2 Regression of the dominant follicle 3 Formation of a Hemorrhagic Anovulatory follicle HAF or Luteinized Unruptured Follicle LUF or 4 Formation of a follicular cyst We hypothesize that atresia of dominant follicles and formation of anovulatory follicular structures will be associated with limited endometrial development In testing these hypotheses we will determine if OCs can safely and effectively be administered at any time during the follicular phase of the menstrual cycle
This study will evaluate the ovarian and uterine responses to administration of a combined dose of 015mg desogestrel 003mg ethinyl estradiol at 1 of 3 different stages of the follicular phase of the menstrual cycle The objectives of the trial are to
Develop new and more user-friendly administration schemes for OC use
Use the administration of OCs at different stages of follicular development in women as a model for studying follicular atresia
Assess the differences in kinetics physiologic status state of viability or atresia and ultrasonographic image attributes of follicles which grow regress ovulate or form anovulatory follicular structures after the administration of exogenous steroid hormones
Assess endometrial response to ovarian suppression by ultrasonographic evaluation of endometrial thickness and endometrial pattern
After screening measurements confirm subject eligibility subjects will be randomized to initiate OC therapy at one of three different times of the menstrual cycle
Experimental Group 1 receives OCs when the dominant follicle reaches 10mm Experimental Group 2 receives OCs when the dominant follicle reaches 14mm Experimental Group 3 receives OCs when the dominant follicle reaches 18mm
Fifteen women will be randomized to each of the 3 experimental groups in a stratified design scheme Data collected from an ongoing OC trial BMC 2000-169 will serve as OC control data n15 Data collected from a previous study BMC 1988-80 will serve as natural cycle control data n60
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CIHR MOP - 11489 | None | None | None |